EXAM 2 Federal Controlled Substance Law Pt6 Flashcards
What are the instructions for controlled substance disposal for registrants (pharmacy) by the DEA?
-destroy on-site (2 destroyers/witnesses)
->both have their autograph on the record (keep the record)
-send for destruction via reverse distributor (most common)
->for destruction and recalls
-> The reverse distributor files the form 41
-request assistance from regional DEA special agent
What is the form 41?
The Registrant’s Inventory of Drugs Surrendered
filed by the reverse distributor for drugs that are sent back to the distributor for destruction or recall
What are the instructions for controlled substance disposal for non-registrants (patients) by the DEA?
-Law enforcement (police department, police officer)
-authorized collectors: pharmacies, Manufacturers, distributors, reverse distributors, narcotic treatment programs, hospitals/clinics, LTCFs
-Mail-back or collection receptacles
->Collection receptacles and the “inner liners” have lots of stipulations ( (should not be easy to open, etc)
Which form is used to report theft or a significant loss of controlled substances?
DEA Form 106 (online)
-also notify the DEA in writing within 1 day of discovery
How long should records and reports of loss be kept?
2 years from the date of records
Where do records need to be kept?
-Central record keeping is allowed with DEA notification
-but there are some documents that need to stay in the registered location (pharmacy)
Which documents need to be kept in the pharmacy?
-Executed 222s (purchase and transfers of C-II)
-POA (power of attorney for others to sign form 222)
-Receipts and invoices for C-III through C-V
-Inventories
-Records of distribution (when selling to another registrant)
-Records of controlled substances dispensed (Rxs, log book for OTC)
-106 (theft and loss)
-DEA registration certificate (digital certificate)
How would you have to file control substance prescriptions in the pharmacy/electronically)
C-II have to be kept separately
can keep C-III, C-IV, and C-V away from non-controlled prescriptions
OR
mix non-controlled with C-III, C-IV, and C-V
-> C-II always by itself
How often should an Inventory be done?
The day the business opens for the first time
(can be done more frequently if needed)
after that: biennially -> every 2 years
may add newly controlled drugs to the inventory (a drug becomes scheduled, add the date of entry)
When is a new inventory required?
-New pharmacist in charge (PIC)
-Theft
How accurately must C-II be counted?
C-II has to be counted exactly
-Count solid dose forms
-Measure liquids/powders to the nearest metric unit volume/weigh
How accurately must C-III, C-IV, and C-Vs be counted?
may be estimated
-if the original container had MORE than 1000 tablets/capsules -> has tu be ACCURATE
if its 1000 you can estimate
-Date of the count
-was it counted befeore opening, or after closing
Which drugs have to be locked in a cabinet or kept behind the counter according to the CMEA?
Combat Methamphetamine Epidemic Act 2005
scheduled listed chemical products (SLCPs)
-Ephedrine
-pseudoephedrine
-phenylpropanolamine (not on the market anymore)
What are the CMEA requirements?
-Products behind counter or in locked cabinet
-Must ID purchaser (unexpired, photo ID issued by state or government)
-Record purchaser name, address, signature, product sold, quantity, date, time
-Maintain logbook (electronic or written) for 2 years
-Must train employees
